As part of an international research project, RIVM has formulated criteria for R&D of sustainable new pharmaceuticals. These GREENER criteria are an important first step to develop pharmaceuticals that do not impact the environment when they enter the water system after use. According to RIVM, environmental experts and pharmaceutical R&D experts should join forces to develop the necessary methods to implement these criteria. This research has been financed by the European Commission. The results have been published in the journal Environmental Science & Technology Letters.
What are GREENER criteria?
Drug discovery and development experts focus on efficacy and safety of pharmaceuticals for the patient. However, there is increasing awareness of the effects that residues of pharmaceuticals may have on water quality. These effects impact our living environment, which is of vital importance for our health.
The GREENER-criteria bring together these perspectives. A pharmaceutical should treat the patient. That is always the most important criterion. At the same time, pharmaceutical R&D could take into account environmental degradability, undesired effects on plants or animals in the environment, or reducing that amount that enters our environment via the patient’s urine. This way, sustainable development (“safe and sustainable by design”) of new active pharmaceutical ingredients can help prevent environmental impacts. The GREENER-criteria aid with this process.
The GREENER-criteria stand for:
| G | Good practice for patients | |
| R | Reduced off-target effects, high specificity | |
| E | Exposure reduction via less emissions | |
| E | Environmental (bio)degradability | |
| N | No PBT (persistent, bioaccumulative as well as toxic) properties | |
| E | Effects reduction: avoid undesirable moieties | |
| R | Risk and hazard mitigation |
Cooperation and future developments
The process of developing pharmaceuticals is very complex and takes many years. It is important that the environmental sector and R&D departments of drug discovery companies know how to find each other. The joint cooperation in formulating the GREENER criteria is an important first step.
These criteria need to be further developed, with attention for the methods needed to test sustainability and environmental safety aspects of active ingredients in the R&D process. World wide purchasing criteria for sustainable pharmaceuticals may accelerate this.
This research has been performed by the PREMIER consortium, a collaboration between scientific research institutes, universities, the European Medicines Agency, and pharmaceutical companies. RIVM is part of this collaboration. The GREENER criteria and some of the necessary methods will be further developed by the PREMIER consortium.
RIVM’s contribution is financed by the European Commission. All research results will be made public.